Kornimate/medical-research-clean huggingface dataset:
intermittent hypoxic training (iht) versus hyperbaric oxygen therapy (hbot) for aerobic performance

Conditions: Healthy Active Athletes

Summary: comparing the effect of hbot and iht on aerobic performance of athletes.

enhanced physical performance is the goal of all professional and non-professional athletes. there are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: iht and hbot. this study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - maximal exercise test for evaluating vo2max and ventilatory thresholds, time to exhaustion, 30 seconds wingate test, agility test, muscle biopsy, blood tests, brain mri, cognitive tests and exercise cognitive test. after signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. the iht group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total. the hbot group will receive 40 daily hyperbaric sessions, five days per week. each session will include 90 minutes exposure to 100% oxygen at 2ata with a five-minute air break every 20 minutes. three times per week, as the iht group, the hbot group will have a guided training session, according an individualized training protocol. both groups, iht and hbot, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. the iht group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at o2 concentration of 15.2% that stimulates a 2500-2600m height. the hbot group will train for 60 minutes after the hbot sessions, 3 times per week, in a normobaric normoxic environment physical performance evaluations will be conducted on 3 different times post interventions - a day last intervention, 3 weeks after and 2 months after - in order to analyze the long term effect of each intervention.

Eligibility criteria:
inclusion criteria: 1. vo2max above 3500 ml or vo2max/kg above 50 ml/kg 2. age 18-45 3. subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week. 4. subject willing and able to read, understand and sign an informed consent exclusion criteria: 1. inability to attend scheduled clinic visits and/or comply with the study protocol 2. active malignancy 3. active smokers 4. previous treatment of hbot for any reason prior to study enrollment. 5. chest pathology incompatible with pressure changes 6. major orthopedic injury at the past 3 months 7. inner ear disease 8. lung pathology 9. the inability to perform an awake brain mri 10. claustrophobia 11. previous neurologic conditions (e.g., epilepsy, brain tumors or s/p neurosurgery etc.) 12. comorbidities and medications that rule out the subject

Keywords: triathletes cyclists mitochondria hbot hbo iht
study of abbv-383 assessing adverse events and clinical activity with subcutaneous (sc) injection in adult participants with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is a cancer of the blood's plasma cells. the cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. treatments are available, but mm can come back (relapsed) or may not get better (refractory) with treatment. this is a study to determine the safety and pharmacokinetics of abbv-383 in adult participants with relapsed/refractory (r/r) mm. abbv-383 is an investigational drug being developed for the treatment of r/r mm. this study is broken into 3 arms: arm a with 2 parts and arm b as an expansion. participants will receive abbv-383 as a subcutaneous (sc) injection and intravenous (iv) infusion in arm a and sc injections of abbv-383 in arm b. around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world in arm a participants will receive one of two doses of abbv-383 as an sc injection and (iv) infusions, during the 151 week study duration. in arm b, participants will receive the selected dose from arm a as sc injections, during the 151 week study duration. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance of \<= 2. * participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-cd38 monoclonal antibody and an immunomodulatory drug. * must be naïve to treatment with abbv-383. exclusion criteria: - received b-cell maturation antigen (bcma)xcd3 bispecific antibody.

Keywords: multiple myeloma abbv-383
monitoring mri changes before and during radiotherapy treatment of brain tumors

Conditions: Brain Tumor

Summary: this study aims to evaluate anatomical and functional changes during rt for patients receiving fractionated rt for brain tumors. anatomical changes during rt will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. this means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. the functional mri sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.


Eligibility criteria:
inclusion criteria: * primary brain tumor (who iv, gbm); treated with fractionated radiotherapy with or without preceding surgery. systemic treatment is allowed before and during radiotherapy. * brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. systemic treatment is allowed before and during radiotherapy. also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the mri executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting). exclusion criteria: * patients receiving whole brain rt (wbrt) * patient with a poor kidney function (gfr \< 30 ml/min; ckd 4 and 5; patients on dialysis and patients with acute kidney insufficiency) * none, doubtful or very small (\<5 mm in its largest dimension) contrast enhancing lesion * patients with a contraindication for mri

Keywords: mri radiotherapy
early application of continuous positive airway pressure in coronavirus patients at risk of obstructive sleep apnea

Conditions: Covid19; Obstructive Sleep Apnea; CPAP Ventilation; Corona Virus Infection

Summary: this was an experimental clinical trial, aim: to evaluate the role of early use of continuous positive airway pressure (cpap) in management of moderate to severe coronavirus disease 2019 patients at risk of obstructive sleep apnea, enrolled patients are randomized into two equal groups;non- cpap group and cpap group. non-cpap group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the egyptian ministry of health 2020 and cpap group as in non-cpap group plus using cpap.

steps included 1. clinical assessment: full history taking were taken from the enrolled coronavirus disease 2019patients including age, occupation, medical history and special habits), coronavirus disease 2019 symptoms (e.g., fever, dyspnea, fatigue, loss of smell or taste, (gastrointestinal tract) symptoms....) as well as all obstructive sleep apnea symptoms (e.g., snoring, insomnia, excessive day time sleepiness, witnessed apnea, ...). 2. ii. scales \& questionnaires: * epworth sleepiness scale (ess) it's designed to assess the degree of daytime sleepiness. * - berlin questionnaire * - (snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference and male gender questionnaire: this scoring system composed of 8 items that are graded from 0 to 8 according to yes/no responses (score: 1/0). 3. iii. radiological investigations 4. iv. laboratory investigations blood gases, complete blood picture, etc 5. . cpap application auto-cpap with continuous nocturnal administration or at least4- 6hours /night and during day naps, for more than 70% of nights from the first night of admission to isolation center

Eligibility criteria:
inclusion criteria: * patients age above 18 years, diagnosed with moderate to severe (coronavirus disease 2019) and at risk of obstructive sleep apnea as well as confirmed nasopharyngeal swab positive for (severe acute respiratory syndrome coronavirus 2) ( by (polymerase chain reaction). exclusion criteria: * patients were excluded from the study if their age \<18 years, hypercapnic, unstable cardiorespiratory (shock) status or respiratory arrest and if there are any contraindications for ( continuous positive airway pressure (cpap) mask use

Keywords: ( coronavirus disease 2019) coronavirus infections sleep breathing disorder obstructive sleep apnea
improving pregnancy outcomes with progesterone

Conditions: Pre-term Birth; HIV-1-infection

Summary: this is a phase iii, double-masked, placebo-controlled, randomized controlled trial taking place in zambia.

weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17p) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. individual participants will be followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * less than 24 0/7 weeks of gestation * viable intrauterine singleton pregnancy confirmed by ultrasound * antibody-confirmed hiv-1 infection * currently receiving antiretroviral l therapy (art) or intending to commence art in pregnancy * ability and willingness to provide written informed consent * intent to remain in current geographical area of residence for the duration of study * willing to adhere to weekly study visit schedule exclusion criteria: * confirmed prior spontaneous preterm birth * multiple gestation * known uterine anomaly * planned or in situ cervical cerclage * major fetal anomaly detected on screening ultrasound * indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean) * threatened abortion, preterm labor, or ruptured membranes at time of enrollment * known allergy or medical comorbidity listed as a contraindication to 17p in the prescribing information * prior participation in the trial * any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.

Keywords: preterm birth hiv-1-infection antiretroviral treatment
axitinib (ag-013736) for the treatment of metastatic renal cell cancer

Conditions: Kidney Neoplasms

Summary: the study is designed to demonstrate that axitinib (ag-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.


Eligibility criteria:
inclusion criteria: * histologically documented metastatic renal cell cancer with a component of clear cell histology. * evidence of measurable disease. * patients with mrcc must have received no prior systemic first-line therapy or must have progressive disease per recist (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both. exclusion criteria: * prior treatment for metastatic renal cell cancer with more that one systemic first line therapy. * major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.

Keywords: axitinib in first & second line treatment of patients with metastatic renal cell cancer
multicenter intervention program to optimize the clinical management of community-acquired pneumonia in hospitals

Conditions: Community Acquired Pneumonia

Summary: the purpose of this study is to evaluate the impact of a structured package (bundle) in reducing the use of antimicrobials and hospital stay of patients with community-acquired pneumonia (cap), and no increase in mortality of these patients in different hospitals.


Eligibility criteria:
inclusion criteria: * diagnosis of cap at hospital admission . * age: 18 years or more. exclusion criteria: * patients with nosocomial pneumonia or criteria related to health care. * patients with severe immunosuppression (hiv infection with \<200 cd4+ lymphocytes / mm3), neutropenia (\<500 neutrophils / mm3). * patient treated with immunosuppressive drugs.
effect of methotrexate on inflammatory response in adult atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a chronic inflammatory skin disease associated with pruritus. methotrexate can be used to treat refractory disease to conventional therapy. it will be conducted a single arm trial with twelve adult patients with moderate to severe ad on methotrexate for 24 weeks. investigators intend to evaluate the effect methotrexate on cytokines and chemokines involved in the inflammatory response, on ige levels, on pruritus, and on easi and scorad severity scores.

introduction: atopic dermatitis (ad) is a chronic inflammatory skin disease associated with pruritus. methotrexate (mtx) can be used to treat refractory disease to conventional therapy, but there are few studies showing its effect on the profile of cytokines involved in the inflammatory response. objectives: to assess the effect of mtx on the cytokines involved in the inflammatory response of adult ad patients treated with methotrexate for 24 weeks. as specific objectives, investigators intend to assess the evolution of serum ige levels, the easi (eczema area and severity index) and scorad (scoring atopic dermatitis) severity scores and pruritus in them. methods: it will be conducted an open, prospective study with twelve adult patients with moderate to severe ad on mtx for 24 weeks. each participant is expected to attend 7 visits during 6 months of follow-up. in clinical healthy and injured skin, two assessments will be performed: 1) mrna expression of il-4, il-10, il-17a, il-22, il-31, oncostatin m receptor (osmr), alpha subunit il-31 (il-31ra) receptor, tnf-α, ifn-γ, tslp, tarc and mdc by real time-pcr at the initial week and week 24; 2) expression of il-31, il-31ra, osmr, tslp and ki67 by immunohistochemistry at the initial week and week 24. skin samples from non-atopic subjects will be utilized as controls for the assays, paired by gender and age. additional analysis of serum levels of ige (nephelometric method) at the initial week and week 24 of the study will be performed. ad severity scores (easi and scorad) will be tested and pruritus will be analyzed by a visual analog scale at the initial, week 12 and week 24.

Eligibility criteria:
inclusion criteria: * ad (hanifin and rajka criteria) moderate to severe (easi ≥ 7.1 and scorad ≥ 25); * age ≥ 18 years; * women without the potential to become pregnant or using an effective method of contraception and with a negative pregnancy blood test; * men without a desire of pregnancy and who use condom in sexual intercourse. exclusion criteria: * hepatic and / or renal insufficiency; * anemia, thrombocytopenia and / or leukopenia; * use of concomitant hepatotoxic drug; * active infection; * allergy to mtx; * excessive alcohol intake; * difficulty to understand how to take methotrexate; * hiv infection or other immunosuppression condition; * therapy with uva or uvb, corticoid, cyclosporine, immunobiological, azathioprine within 12 weeks prior to introduction of methotrexate.

Keywords: atopic dermatitis pruritus methotrexate inflamation il-31
percutaneous interventions in adults with chd

Conditions: Congenital Disorders

Summary: the primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair.

this is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including eisenmenger's syndrome, single ventricle, pulmonary atresia with aorticopulmonary collaterals, complete atrio-ventricular canal defects, double inlet left ventricle, heterotaxy syndromes and truncus arteriosus. patients with surgically placed systemic to pulmonary artery shunts will be included. although generally incompatible with adult survival, rare patients with un-operated or palliated complex cyanotic congenital heart defects (cchd) survive well into adulthood. symptoms related to poor pulmonary blood flow and/ or increasing pulmonary vascular resistance progress with advancing age. percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease. percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types: percutaneous occlusion of shunt lesions, percutaneous balloon valvotomy or valvuloplasty, and balloon angioplasty and stenting of vascular structures (1). percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described (2,3). however, procedures to improve pulmonary blood flow in adults with cchd have not previously been described.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * complex cyanotic heart disease * oxygen saturation prior to intervention \< 90% exclusion criteria: * those who do not meet inclusion criteria

Keywords: adult congenital heart disease percutaneous occlusion percutaneous balloon valvotomy balloon angioplasty complex cyanotic congenital heart defects (cchd)
a study to determine biopsy rate in participants with a first relapse of breast cancer

Conditions: Breast Cancer

Summary: this is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. the duration of the study will be approximately 24 months.


Eligibility criteria:
inclusion criteria: * participants with histologically confirmed breast cancer treated for early breast cancer (ebc) with first metastatic relapse disease in the period from january 1, 2014 and december 31, 2015 exclusion criteria: not applicable
acupuncture research on lung cancer patients with cancer related fatigue（crf）

Conditions: Lung Cancer; Cancer Related Fatigue

Summary: we plan to conduct this trial to find out： * if acpuncture treatment could relieve crf among lung cancer patients receiving chemo- or radio-therapy？ * how about the extent it relieves？the safety and applicability ？ * what's the possible influential factor and mechanism ？


Eligibility criteria:
inclusion criteria: * patients who are pathologically/cytologically diagnosed as nsclc and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment; * participants who meet the diagnosis criteria of crf（icd-10 criteria); * the first time to receive acupuncture treatment; * the age is between 18 and 65 years old; * mean baseline fatigue as measured by the brief fatigue inventory (bfi) must be four or above; * ecog performance status 0, 1 or 2. * patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /l, platelet count ≥ 100 x 109/l, hemoglobin ≥ 85 g/l, serum creatinine \ 30g/l. * have not taken any hypnotic, melatonin, or antidepressants within 30 days; * willing to finish the whole observation period; * with written consent form signed by themselves. exclusion criteria: * participants in other clinical research; * can not be pathologically or cytologically diagnosed as nsclc; * ecog 3\~4; * pregnant woman; * \>65 or \<18 years old; * patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue; * patients who have received acupuncture ever before; * received surgery, immunotherapy or target therapy within one month before the recruition； * taking warfarin or heparin, a bleeding tendency exists; * infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections； * there are cerebral vascular accident history or spinal cord injury history； * combination with other serious diseases or condition, including congestive heart failure, unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.; * patients with a life expectancy \< 3 months; * patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
efficacy of transcranial direct current stimulation for severe primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: primary dysmenorrhea (pdm), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. novel therapeutic method is in need for pain alleviation for this particular phenotype. we have previously reported that pdm females may engage motor-cortex based descending pain modulation system in our resting-state functional magnetic resonance imaging (rs-fmri) and thermal pain-activation fmri studies. based on the reported analgesic efficacy of transcranial direct current stimulation (tdcs) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tdcs can be effective for the severe and medication-refractory pdm patients. this study aim to investigate the analgesic efficacy of tdcs in severe pdms and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (fc) of pain matrix after tdcs intervention. we will recruit 30 severe pdms and randomly allocate them to either real or sham group in a triple-blind manner. rs-fmri for functional connectivity analysis will be performed before and after the tdcs intervention. the imaging data will be correlated with behavioral and psychological measurements. this is the first study in the literature investigating the tdcs efficacy for severe pdm. the result can promise a new possibility for clinical application.


Eligibility criteria:
inclusion criteria: * 20-35 years old pdm patients * right-handedness * a regular menstrual cycle: 27-32 days * cramping pain during the menstrual period in the last 6 months , vas ≧ 7 * abstinence for daily activities due to pdm * need analgesic or physical therapy despite of no prominent effect exclusion criteria: * history of head injury * pathological pituitary gland disease * organic pelvic disease, psychiatric disorder * pregnancy, childbirth * a metal or pacemaker implant. * take hormone agents within 6 months

Keywords: dysmenorrhea neuromodulation transcranial direct current stimulation neuroimaging neuroplasticity